MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558360

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Note: this report pertains to one of two cre fixed wire dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two cre fixed wire dilatation balloons were used during a procedure performed on (b)(6), 2023.During the procedure, the contrast agent leaked from the balloon.The same problem occurred with the second cre fixed wire dilatation balloon.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Note: the anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.

Manufacturer Narrative

Block e1: the initial reporter facility name: (b)(6).Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in an unknown anatomy location.

Manufacturer Narrative

Block e1: the initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in an unknown anatomy location.Block h10: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the balloon (distal section), located approximately 50 mm from the tip.Microscopic inspection found a pinhole located approximately at 50 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The results of the analysis performed on the returned device found that the balloon had a pinhole located approximately at 50 mm from the tip of the device.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.

Event Description

Note: this report pertains to one of two cre fixed wire dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two cre fixed wire dilatation balloons were used during a procedure performed on (b)(6) 2023.During the procedure, the contrast agent leaked from the balloon.The same problem occurred with the second cre fixed wire dilatation balloon.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Note: the anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18447568
• MDR Text Key: 332151749
• Report Number: 3005099803-2023-06990
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558360
• Device Catalogue Number: 5836
• Device Lot Number: 0031571143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1